@文章{信息:doi/10.2196/31333，作者=“Koldeweij, Charlotte和Clarke, Jonathan和Nijman, Joppe和Feather, Calandra和de Wildt, Saskia N和Appelbaum, Nicholas”，标题=“CE认证和用于移动设备的儿科药物计算器的CE标记的障碍:范围审查和定性分析”，期刊=“J Med Internet Res”，年=“2021”，月=“12”，日=“13”，卷=“23”，数=“12”，页=“e31333”，关键词=“儿科;药量计算器;欧洲法规;安全;医疗设备;医疗事故;应用程序;应用程序;移动健康;背景:根据医疗器械指令和医疗器械法规，用于临床使用的儿科药物计算器(PDCs)符合医疗器械的资格。 The extent to which they comply with European standards on quality and safety is unknown. Objective: This study determines the number of PDCs available as mobile apps for use in the Netherlands that bear a CE mark, and explore the factors influencing the CE marking of such devices among app developers. Methods: A scoping review of Google Play Store and Apple App Store was conducted to identify PDCs available for download in the Netherlands. CE accreditation of the sampled apps was determined by consulting the app landing pages on app stores, by screening the United Kingdom Medicines and Healthcare products Regulatory Agency's online registry of medical devices, and by surveying app developers. The barriers to CE accreditation were also explored through a survey of app developers. Results: Of 632 screened apps, 74 were eligible, including 60 pediatric drug dosage calculators and 14 infusion rate calculators. One app was CE marked. Of the 20 (34{\%}) respondents to the survey, 8 considered their apps not to be medical devices based on their intent of use or functionality. Three developers had not aimed to make their app available for use in Europe. Other barriers that may explain the limited CE accreditation of sampled PDC apps included poor awareness of European regulations among developers and a lack of restrictions when placing PDCs in app stores. Conclusions: The compliance of PDCs with European standards on medical devices is poor. This puts clinicians and their patients at risk of medical errors resulting from the largely unrestricted use of these apps. ", issn="1438-8871", doi="10.2196/31333", url="//www.mybigtv.com/2021/12/e31333", url="https://doi.org/10.2196/31333", url="http://www.ncbi.nlm.nih.gov/pubmed/34898456" }